An interventional study of Whole-Food, Plant-Based Diet and Low-Carbohydrate Diet in Heart Disease, Ischemic, Hyperlipidemias and Hypertension, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-07-16.
Sponsored by University of Rochester · Not applicable, Interventional, and Treatment
This is a randomized trial with a crossover design to investigate the short-term effects of two different dietary patterns on markers of vascular health. A low-carbohydrate diet and a whole-food, plant-based diet will be used. In addition to more traditional markers (cholesterol, blood pressure, inflammation), endothelial progenitor cells and trimethylamine N-oxide will be assessed.
This study is an investigation of the short-term effects of two different diets on both conventional as well as newer markers of vascular health among subjects over the age of 50 who have a cardiovascular risk factor. The low-carbohydrate diet will be consistent with low-carbohydrate diet maintenance plans, with "net" carbs kept under 50g per day. The whole-food, plant-based diet will exclude animal foods, oils, and solid fats. Meals will be provided, and subjects will consume each diet for 2 weeks, with a 4-6 week washout period between dietary phases. Subjects will be randomized 1:1 to start with either the plant-based diet or the low-carbohydrate diet. Its primary aim is to assess the short-term effect of a whole-food, plant-based diet and a low-carbohydrate diet on levels of endothelial progenitor cells and trimethylamine N-oxide among this population. Secondarily, we will assess more conventional measures of vascular risk, including cholesterol, weight, blood pressure, insulin resistance, and inflammatory marker, as well as fullness and changes in nutritional intake.
3,242 studies on the registry are indexed under Myocardial Ischemia; 390 are open to participants now.
This study's enrollment of 45 is below the median of 120 across 1,901 interventional studies indexed under Myocardial Ischemia.
Browse Myocardial Ischemia studies →University of Rochester is the lead sponsor of 728 studies on the registry; 115 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
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Exclusion Criteria:
This group starts with the whole-food, plant-based diet, then gets the low-carbohydrate diet after the washout period.
Other: Whole-Food, Plant-Based Diet and Low-Carbohydrate Diet
This group starts with the low-carbohydrate diet, then gets the whole-food, plant-based diet after the washout period.
Other: Whole-Food, Plant-Based Diet and Low-Carbohydrate Diet
Participants will consume two weeks of each diet, with a 4-6 week washout period in between. Meals and snacks are provided for convenience to enhance adherence to each dietary pattern, but subjects can add or include their own home-prepared foods as long as they meet dietary guidelines. Each dietary intervention will include an education session via Zoom teleconference, and at least 2 individual contacts by phone to address questions and assess for adverse events.
Endothelial Progenitor Cells
Time frame: 2 weeks
trimethylamine N-oxide
Time frame: 2 weeks
HDL function
Time frame: 2 weeks
Cholesterol Panel
Total, LDL, HDL, non-HDL cholesterol, and triglycerides
Time frame: 2 weeks
Blood Pressure
Time frame: 2 Weeks
Resting Heart Rate
Time frame: 2 weeks
Weight
Time frame: 2 weeks
Insulin resistance
HOMA-IR
Time frame: 2 weeks
Insulin
Time frame: 2 weeks
Blood Glucose
Time frame: 2 weeks
Inflammatory Markers
hsCRP, TNF-a, IL-6
Time frame: 2 weeks
Satiety Assessment
Adapted SLIM (satiety labeled intensity magnitude)
Time frame: 2 weeks
Food "liking"
5 food liking factor scales adapted from 5-Factor Satiety Questionnaires
Time frame: 2 weeks
Change in nutritional intake
assessed by 3 day food records at baseline and in second week of dietary phase
Time frame: 2 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Dec 2022 to primary completion in Apr 2024, 16 months.
Of 427 non-industry interventional studies with no phase under Myocardial Ischemia, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's 16 months is below that.
Counting every sponsor, half of 492 studies reached it within 28 months; a quarter within 13 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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